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Arrow Declarations

FUJIFILM KYOWA V ABBVIE [2016] EWHC 2204 (PAT)

Arrow Declarations are declarations regarding the validity of subject-matter (rather than specific patents) and provide accused infringers of legal certainty that their proposed activities will not fall within the scope of any valid patent that may be granted in the future.
In Fujifilm Kyowa v AbbVie, Mr Justice Arnold refused to strike out Fujifilm’s request for an Arrow Declaration based on “bad faith” acts carried out by AbbVie in previous proceedings before the UK Court.

Arrow Declarations

The term "Arrow Declaration" refers to a declaration that the subject-matter of an invention is not patentable. The term stems from the case Arrow v
Merck [2007] EWHC 1900 (Pat) where such a declaration was first issued. Unlike "traditional" declarations issued by the courts in patent cases, the
declaration does not refer to a specific patent, but instead it covers any patents (normally those which have not yet granted) which cover the
subject-matter which is the subject of that declaration.

Arrow declarations are particularly useful where the patent proprietor files or is likely to file a number of divisional applications, which he/she can
then consecutively attempt to enforce after grant. This increases the time and cost required for third parties to clear the way for their planned
commercial activities.

The Case

Fujifilm sought an Arrow declaration that the subject matter of a pending divisional application owned by AbbVie that covered the antibody adalimumab
(marketed as Humira) was not patentable. More specifically, the declaration sought that:

"importing into the UK and offering to sell and dispose of, and to sell and dispose, and to keep for such sale or disposal in the UK the Claimant's
products containing their biosimilar antibody to … adalimumab (Humira) would insofar as the Higher Initial Dosing Regimens are concerned have been
obvious and/or anticipated at the date from which EP (UK) 1,737,491 is entitled to claim priority. Such Higher Initial Dosing Regimens are dosing regiments
for each of psoriasis, Crohn's disease and ulcerative colitis in the Humira SmPC comprising higher initial doses (as multiple initial doses of 40 mg via
subcutaneous injection) as follows:

a. 80 mg for psoriasis;

b. 80 mg, or 160 mg then 80 mg, for Crohn's disease; and

c. 160 mg then 80 mg for ulcerative colitis

each of which is followed by one or more doses of 40 mg."

Fujifilm also sought an injunction against AbbVie commencing infringement proceedings or threatening with infringement proceedings in relation to these
acts.

AbbVie applied to have the request for the declaration and injunction struck out from the claim. AbbVie argued that Fujifilm's case was
unsupportable and had no real prospect of success. Further, in Arrow v Merck the declaration was issued on the basis that the circumstances of
the case were most unusual, whereas AbbVie did not believe this to apply to their case.

The judge agreed with Fujifilm's arguments that there was a real prospect of AbbVie shielding at least some of the subject matter of its European
application from the UK courts, as it had done in previous proceedings (where AbbVie had filed a divisional and abandoned the parent patent to attempt to
shield the patent from the UK courts).

AbbVie further argued that as the patent application was in the name of AbbVie Biotechnology Ltd, a company incorporated in Bermuda, the declaration and
injunction could not be awarded against AbbVie Limited (a UK company), AbbVie Limited (UK) had no interest in the subject matter of the application.
Having reviewed the relevant case law, Mr Justice Arnold held that there was no requirement that the party who the declaration was issued against have an
interest in the subject matter.